Optimal Adalimumab Plasma Concentrations in Ankylosing Spondylitis Patients

• Conditions: Ankylosing Spondylitis
• Interventions: Other: The study is observational

• Registration Number: NCT04875299
• Lead Sponsor: The First Affiliated Hospital of Soochow University

Brief Summary

The optimal plasma concentration range of adalimumab in Chinese patients with active ankylosing spondylitis remains unknown, the aims of this study is to determine the concentration-effect relationship, and explore the effect of anti-drug antibody or biomarkers on clinical outcomes in a real-world setting.

Detailed Description

This prospective observational study will include Chinese adult patients with active ankylosing spondylitis receiving adalimumab treatment. The primary outcome is the mean change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS).

Study Timeline

• Study First Submitted: 2021-04-29
• Study First Submitted QC: 2021-05-04
• Study First Posted: 2021-05-06
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-20
• Last Update Posted: 2021-08-25
• Study Start: 2021-09
• Primary Completion: 2023-01
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

1. Consent of the patient.
2. Patient who meets the definition of Ankylosing Spondylitis based on the 1984 Modified New York Criteria, has a diagnosis of active Ankylosing Spondylitis (BASDAI ≥ 4, Back pain ≥ 4).
3. Patients who have indication of adalimumab.
4. Patients on NSAIDs treatment need to be on a stable dose for at least 4 weeks.

Exclusion Criteria

(1) Hepatitis B or tuberculosis patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
adalimumab TDM	The study is observational	Patients with active ankylosing spondylitis receiving adalimumab treatment.

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in ASDAS	Week 24	ASDAS will be measured at week 24 and will be compared to baseline

Secondary Outcome Measures

Name	Time	Method
ASAS20 response	Week 2, 4, 8, 12, 24	ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement (vs. baseline) and an absolute improvement ≥ 10 units on a 0-100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening (defined as a worsening of ≥ 20% and a net worsening of ≥ 10 units) in the remaining domain.
ASAS40 response	Week 2, 4, 8, 12, 24	ASAS 40 = 40% improvement (vs. baseline) and an absolute improvement ≥ 20 units on a 0-100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening (defined as a worsening of ≥ 20% and a net worsening of ≥ 10 units) in the remaining domain.
BASDAI50 response	Week 2, 4, 8, 12, 24	Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) subjects answered 6 questions measuring discomfort, pain, fatigue, and morning stiffness. BASDAI 50 = at least 50% improvement (vs. baseline) in BASDAI.
ASDAS response	Week 2, 4, 8, 12, 24	A decrease in ASDAS from baseline (△ASDAS) ≥ 2.0 or a moderate disease activity achievement (ASDAS \< 2.1) with △ASDAS ≥ 1.1 is considered as response
ASDAS remission	Week 2, 4, 8, 12, 24	ASDAS \< 2.1 at assessment time point is considered as remission
Safety analysis - Occurence of adverse event	Week 24	Safety analysis include occurence of adverse event

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China